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Imports Regulatory Oversight Food and Drug Administration (FDA)

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

Ropes & Gray LLP on

In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

Hogan Lovells

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

Hogan Lovells on

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. This announcement applies to facilities that produce...more

Morgan Lewis

From Offshore to Onshore: Considerations for Pharmaceutical Industry Stakeholders Amid New Domestic Drug Manufacturing EO

Morgan Lewis on

The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more

Morgan Lewis

Key Considerations for Foreign Clinical Trials When Looking Abroad for Product Development

Morgan Lewis on

With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts...more

DLA Piper

Food and Beverage News and Trends - September 2024 #2

DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape....more

Troutman Pepper Locke

FDA Proposes Submission Tracking Number Requirement for ENDS Imports

Troutman Pepper Locke on

In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more

K&L Gates LLP

An Overview of the US Food and Drug Administration's Legislative Goals (Part I)

K&L Gates LLP on

In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more

Hogan Lovells

FDA issues final guidance on oversight of food covered by Systems Recognition Arrangements

Hogan Lovells on

This week, the U.S. Food and Drug Administration (FDA) issued final guidance concerning regulatory oversight of food imported from Systems Recognition Arrangement (SRA) countries. FDA employs a Systems Recognition (SR)...more

Hogan Lovells

FDA updates on efforts to assist U.S. companies with China’s new food facility regulation

Hogan Lovells on

On October 22, 2021, the U.S. Food and Drug Administration (FDA) published an update on its efforts to assist US companies on China’s implementation of a new registration requirement for all food facilities importing foods...more

Hogan Lovells

FDA reviews New Era of Smarter Food Safety accomplishments

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued a review of work done over the last year in advancing its New Era of Smarter Food Safety (New Era) Blueprint, which was released in July 2020. In a corresponding FDA...more

Hogan Lovells

FDA issues draft guidance on oversight of food products covered by Systems Recognition Arrangements

Hogan Lovells on

For the past several years, the U.S. Food and Drug Administration (FDA) has used a “Systems Recognition” approach with its foreign regulatory counterparts, through which the FDA evaluates whether its foreign counterpart...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update - July 2020

FDA Enters New Phase Of FSVP Enforcement - The U.S. Food and Drug Administration (FDA) has entered a new phase of enforcement for the Foreign Supplier Verification Program (FSVP) regulation, the legally required due...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | April 2020

What the FDA Requires for Food Safety During the COVID-19 Pandemic - The U.S. Food and Drug Administration’s (FDA) regulatory requirements for food companies, including manufacturers and importers, remain largely unchanged...more

Hogan Lovells

OMB Releases Fall 2019 Unified Agenda of Regulatory Actions

Hogan Lovells on

The Office of Management and Budget (OMB) recently released the Fall 2019 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l December 2019

LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Warning Letters, Consumer Update On CBD, Sparking Litigation Against CBD Cos. - The U.S. Food and Drug Administration (FDA) has issued a consumer update on cannabidiol...more

Hogan Lovells

FDA Issues Laboratory Accreditation Proposed Rule Required Under FSMA

Hogan Lovells on

The U.S. Food and Drug Administration (“FDA”) recently issued a proposed rule entitled “Laboratory Accreditation for Analyses of Foods” (“Proposed Rule”), which was mandated by the FDA Food Safety Modernization Act (FSMA)....more

Hogan Lovells

FSMA Update: FDA Publishes List of Required Foreign Supplier Verification Program Records

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently published a list of the records that importers are required to develop and maintain under the Foreign Supplier Verification Program (FSVP) regulation....more

Akerman LLP - Health Law Rx

FDA’s Safe Importation Action Plan May Give Florida’s Drug Import Program a Pathway to Approval

At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies.  President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...more

Perkins Coie

Industry Insights: FDA Sends First Warning Letter Under Recent Rule Regarding Imported Food

Perkins Coie on

The Food Safety Modernization Act (“FSMA”) ushered in a sea change in the government’s regulation of food safety. Pursuant to FSMA, the FDA has promulgated a series of rules, including a 2015 rule related to the Foreign...more

Hogan Lovells

FDA Announces Reinspection and VQIP Fees for Fiscal Year 2020

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The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation in the Voluntary Qualified Importer Program...more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

Hogan Lovells on

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

Hogan Lovells

FDA Releases Strategy for the Safety of Imported Food

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently released the “FDA Strategy for the Safety of Imported Food” (the Strategy), which outlines the agency’s approach to ensuring the safety of the ever-rising volume of...more

Hogan Lovells

USDA and FDA Settle Jurisdiction over Products Derived from Livestock and Poultry Cell Lines

Hogan Lovells on

The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) announced today a formal-agreement coordinating joint jurisdiction over the production of...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | August 2018

LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Modernization for Dairy Product Identities - Following his related statements at a conference, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | April 2018 #2

China to Tariff U.S. Food Commodities - China has reportedly imposed tariffs on imports of U.S.-made agricultural products, including pork, soybeans, wheat, beef, orange juice, whiskey and corn, following the United...more

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